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Published in: Supportive Care in Cancer 12/2018

01-12-2018 | Original Article

Incidence of nausea and vomiting in breast cancer patients treated with anthracycline plus cyclophosphamide-based chemotherapy regimens in Italy: NAVY observational study

Authors: Michelino De Laurentiis, Chiara Bonfadini, Vito Lorusso, Giuseppina Cilenti, Francesca Di Rella, Giuseppe Altavilla, Manuela Otero, Antonio Ardizzoia, Paolo Marchetti, Giorgia Peverelli, Domenico Amoroso, Stefania Vecchio, Elena Fiorio, Simona Orecchia

Published in: Supportive Care in Cancer | Issue 12/2018

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Abstract

Purpose

Chemotherapy-induced nausea and vomiting (CINV) is a common adverse event with cancer chemotherapy, despite the availability of effective antiemetic agents. This is a prospective observational study of Italian breast cancer patients treated with anthracycline plus cyclophosphamide (AC), assessed CINV incidence, adherence to national antiemetic guidelines (AIOM 2012), and the relationship with CINV outcomes.

Methods

Patients with breast cancer scheduled to receive their first cycle of an AC-based regimen were enrolled at 12 Italian centers and their clinical data prospectively recorded. CINV incidence was assessed from patient diaries after the first chemotherapy cycle. The relationship between guideline adherence and CINV outcomes was examined using multiple logistic regression.

Results

The overall incidence rates of nausea and vomiting among 246 evaluable patients were 63.0 and 25.4%, respectively. Most patients received a 5-HT3-RA agent and dexamethasone for acute phase CINV prophylaxis, whereas a triple combination including aprepitant (NK1-RA), consistent with national guidelines, was used in only 45.5% of cases. In the delayed phase, the guideline adherence was 48.8%, while the overall adherence was 43.5%. After adjusting for confounding factors, adherence to antiemetic prophylaxis guidelines was associated with a significant reduction in the odds of three endpoints, namely any nausea, “significant nausea,” and vomiting (OR = 0.49, OR = 0.54, and OR = 0.48, respectively), and a 90% increase in the odds of overall complete protection (OR = 1.90).

Conclusions

CINV is still a critical issue in AC-treated patients, despite antiemetic treatment. Non-adherence to antiemetic guidelines may lead to poorer outcomes and indicates the need for strategies to enhance the use of guidelines in clinical practice.
Literature
1.
go back to reference de Boer-Dennert M, de Wit R, Schmitz PI, Djontono J, v Beurden V, Stoter G, Verweij J (1997) Patient perceptions of the side-effects of chemotherapy: the influence of 5HT3 antagonists. Br J Cancer 76:1055–1061CrossRef de Boer-Dennert M, de Wit R, Schmitz PI, Djontono J, v Beurden V, Stoter G, Verweij J (1997) Patient perceptions of the side-effects of chemotherapy: the influence of 5HT3 antagonists. Br J Cancer 76:1055–1061CrossRef
2.
go back to reference Cohen L, de Moor CA, Eisenberg P, Ming EE, Hu H (2007) Chemotherapy-induced nausea and vomiting: incidence and impact on patient quality of life at community oncology settings. Support Care Cancer 15:497–503CrossRef Cohen L, de Moor CA, Eisenberg P, Ming EE, Hu H (2007) Chemotherapy-induced nausea and vomiting: incidence and impact on patient quality of life at community oncology settings. Support Care Cancer 15:497–503CrossRef
3.
go back to reference Bloechl-Daum B, Deuson RR, Mavros P, Hansen M, Herrstedt J (2006) Delayed nausea and vomiting continue to reduce patients' quality of life after highly and moderately emetogenic chemotherapy despite antiemetic treatment. J Clin Oncol 24:4472–4478CrossRef Bloechl-Daum B, Deuson RR, Mavros P, Hansen M, Herrstedt J (2006) Delayed nausea and vomiting continue to reduce patients' quality of life after highly and moderately emetogenic chemotherapy despite antiemetic treatment. J Clin Oncol 24:4472–4478CrossRef
4.
go back to reference Hesketh PJ (2008) Chemotherapy-induced nausea and vomiting. N Engl J Med 358:2482–2494CrossRef Hesketh PJ (2008) Chemotherapy-induced nausea and vomiting. N Engl J Med 358:2482–2494CrossRef
5.
go back to reference Feyer P, Jordan K (2011) Update and new trends in antiemetic therapy: the continuing need for novel therapies. Ann Oncol 22:30–38CrossRef Feyer P, Jordan K (2011) Update and new trends in antiemetic therapy: the continuing need for novel therapies. Ann Oncol 22:30–38CrossRef
6.
go back to reference Basch E, Prestrud AA, Hesketh PJ, Kris MG, Feyer PC, Somerfield MR, Chesney M, Clark-Snow RA, Flaherty AM, Freundlich B, Morrow G, Rao KV, Schwartz RN, Lyman GH, American Society of Clinical Oncology (2011) Antiemetics: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol 29:4189–4198CrossRef Basch E, Prestrud AA, Hesketh PJ, Kris MG, Feyer PC, Somerfield MR, Chesney M, Clark-Snow RA, Flaherty AM, Freundlich B, Morrow G, Rao KV, Schwartz RN, Lyman GH, American Society of Clinical Oncology (2011) Antiemetics: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol 29:4189–4198CrossRef
7.
go back to reference Hesketh PJ, Bohlke K, Lyman GH, Basch E, Chesney M, Clark-Snow RA, Danso MA, Jordan K, Somerfield MR, Kris MG, American Society of Clinical Oncology (2016) Antiemetics: American Society of Clinical Oncology focused guideline update. J Clin Oncol 34:381–386CrossRef Hesketh PJ, Bohlke K, Lyman GH, Basch E, Chesney M, Clark-Snow RA, Danso MA, Jordan K, Somerfield MR, Kris MG, American Society of Clinical Oncology (2016) Antiemetics: American Society of Clinical Oncology focused guideline update. J Clin Oncol 34:381–386CrossRef
12.
go back to reference Aapro M, Molassiotis A, Dicato M, Peláez I, Rodríguez-Lescure Á, Pastorelli D, Ma L, Burke T, Gu A, Gascon P, Roila F, investigators PEER (2012) The effect of guideline-consistent antiemetic therapy on chemotherapy-induced nausea and vomiting (CINV): the Pan European Emesis Registry (PEER). Ann Oncol 23:1986–1992CrossRef Aapro M, Molassiotis A, Dicato M, Peláez I, Rodríguez-Lescure Á, Pastorelli D, Ma L, Burke T, Gu A, Gascon P, Roila F, investigators PEER (2012) The effect of guideline-consistent antiemetic therapy on chemotherapy-induced nausea and vomiting (CINV): the Pan European Emesis Registry (PEER). Ann Oncol 23:1986–1992CrossRef
13.
go back to reference Mertens WC, Higby DJ, Brown D, Parisi R, Fitzgerald J, Benjamin EM, Lindenauer PK (2003) Improving the care of patients with regard to chemotherapy-induced nausea and emesis: the effect of feedback to clinicians on adherence to antiemetic prescribing guidelines. J Clin Oncol 21:1373–1378CrossRef Mertens WC, Higby DJ, Brown D, Parisi R, Fitzgerald J, Benjamin EM, Lindenauer PK (2003) Improving the care of patients with regard to chemotherapy-induced nausea and emesis: the effect of feedback to clinicians on adherence to antiemetic prescribing guidelines. J Clin Oncol 21:1373–1378CrossRef
14.
go back to reference Dranitsaris G, Leung P, Warr D (2001) Implementing evidence based antiemetic guidelines in the oncology setting: results of a 4-month prospective intervention study. Support Care Cancer 9:611–618CrossRef Dranitsaris G, Leung P, Warr D (2001) Implementing evidence based antiemetic guidelines in the oncology setting: results of a 4-month prospective intervention study. Support Care Cancer 9:611–618CrossRef
15.
go back to reference Roila F (2004) Transferring scientific evidence to oncological practice: a trial on the impact of three different implementation strategies on antiemetic prescriptions. Support Care Cancer 12:446–453CrossRef Roila F (2004) Transferring scientific evidence to oncological practice: a trial on the impact of three different implementation strategies on antiemetic prescriptions. Support Care Cancer 12:446–453CrossRef
16.
go back to reference Grunberg SM, Deuson RR, Mavros P, Geling O, Hansen M, Cruciani G, Daniele B, De Pouvourville G, Rubenstein EB, Daugaard G (2004) Incidence of chemotherapy-induced nausea and emesis after modern antiemetics. Cancer 100:2261–2268CrossRef Grunberg SM, Deuson RR, Mavros P, Geling O, Hansen M, Cruciani G, Daniele B, De Pouvourville G, Rubenstein EB, Daugaard G (2004) Incidence of chemotherapy-induced nausea and emesis after modern antiemetics. Cancer 100:2261–2268CrossRef
17.
go back to reference Majem M, Moreno ME, Calvo N, Feliu A, Pérez J, Mangues MA, Barnadas A (2011) Perception of healthcare providers versus patient reported incidence of chemotherapy-induced nausea and vomiting after the addition of NK-1 receptor antagonists. Support Care Cancer 19:1983–1990CrossRef Majem M, Moreno ME, Calvo N, Feliu A, Pérez J, Mangues MA, Barnadas A (2011) Perception of healthcare providers versus patient reported incidence of chemotherapy-induced nausea and vomiting after the addition of NK-1 receptor antagonists. Support Care Cancer 19:1983–1990CrossRef
18.
go back to reference Pastorelli D, Locatelli MA, Melotti B, Pisano C, Turano S, Mellino U, Provinciali N, Marchetti P, Dazzi C, Berretta M, Giordano A, Lorusso V (2013) The Pan European Emesis Registry (PEER): a critical appraisal of the Italian experience. J Chemother 25:309–317CrossRef Pastorelli D, Locatelli MA, Melotti B, Pisano C, Turano S, Mellino U, Provinciali N, Marchetti P, Dazzi C, Berretta M, Giordano A, Lorusso V (2013) The Pan European Emesis Registry (PEER): a critical appraisal of the Italian experience. J Chemother 25:309–317CrossRef
19.
go back to reference Ng TL, Hutton B, Clemons M (2015) Chemotherapy-induced nausea and vomiting: time for more emphasis on nausea? Oncologist 20:576–583CrossRef Ng TL, Hutton B, Clemons M (2015) Chemotherapy-induced nausea and vomiting: time for more emphasis on nausea? Oncologist 20:576–583CrossRef
20.
go back to reference Hutton B, Clemons M, Mazzarello S, Kuchuk I, Skidmore B, Ng T (2015) Identifying an optimal antiemetic regimen for patients receiving anthracycline and cyclophosphamide-based chemotherapy for breast cancer—an inspection of the evidence base informing clinical decision-making. Cancer Treat Rev 41:951–959CrossRef Hutton B, Clemons M, Mazzarello S, Kuchuk I, Skidmore B, Ng T (2015) Identifying an optimal antiemetic regimen for patients receiving anthracycline and cyclophosphamide-based chemotherapy for breast cancer—an inspection of the evidence base informing clinical decision-making. Cancer Treat Rev 41:951–959CrossRef
21.
go back to reference The Italian Group for Antiemetic Research (2000) Dexamethasone alone or in combination with ondansetron for the prevention of delayed nausea and vomiting induced by chemotherapy. N Engl J Med 342:1554–1559CrossRef The Italian Group for Antiemetic Research (2000) Dexamethasone alone or in combination with ondansetron for the prevention of delayed nausea and vomiting induced by chemotherapy. N Engl J Med 342:1554–1559CrossRef
22.
go back to reference Latreille J, Pater J, Johnston D, Laberge F, Stewart D, Rusthoven J, Hoskins P, Findlay B, McMurtrie E, Yelle L, Williams C, Walde D, Ernst S, Dhaliwal H, Warr D, Shepherd F, Mee D, Nishimura L, Osoba D, Zee B (1998) Use of dexamethasone and granisetron in the control of delayed emesis for patients who receive highly emetogenic chemotherapy. National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol 16:1174–1178CrossRef Latreille J, Pater J, Johnston D, Laberge F, Stewart D, Rusthoven J, Hoskins P, Findlay B, McMurtrie E, Yelle L, Williams C, Walde D, Ernst S, Dhaliwal H, Warr D, Shepherd F, Mee D, Nishimura L, Osoba D, Zee B (1998) Use of dexamethasone and granisetron in the control of delayed emesis for patients who receive highly emetogenic chemotherapy. National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol 16:1174–1178CrossRef
23.
go back to reference Goedhals L, Heron JF, Kleisbauer JP, Pagani O, Sessa C (1998) Control of delayed nausea and vomiting with granisetron plus dexamethasone or dexamethasone alone in patients receiving highly emetogenic chemotherapy: a double-blind, placebo-controlled, comparative study. Ann Oncol 9:661–666CrossRef Goedhals L, Heron JF, Kleisbauer JP, Pagani O, Sessa C (1998) Control of delayed nausea and vomiting with granisetron plus dexamethasone or dexamethasone alone in patients receiving highly emetogenic chemotherapy: a double-blind, placebo-controlled, comparative study. Ann Oncol 9:661–666CrossRef
24.
go back to reference Tsukada H, Hirose T, Yokoyama A, Kurita Y (2001) Randomised comparison of ondansetron plus dexamethasone with dexamethasone alone for the control of delayed cisplatin-induced emesis. Eur J Cancer 37:2398–2404CrossRef Tsukada H, Hirose T, Yokoyama A, Kurita Y (2001) Randomised comparison of ondansetron plus dexamethasone with dexamethasone alone for the control of delayed cisplatin-induced emesis. Eur J Cancer 37:2398–2404CrossRef
25.
go back to reference Warr DG, Hesketh PJ, Gralla RJ, Muss HB, Herrstedt J, Eisenberg PD, Raftopoulos H, Grunberg SM, Gabriel M, Rodgers A, Bohidar N, Klinger G, Hustad CM, Horgan KJ, Skobieranda F (2005) Efficacy and tolerability of aprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients with breast cancer after moderately emetogenic chemotherapy. J Clin Oncol 23:2822–2830CrossRef Warr DG, Hesketh PJ, Gralla RJ, Muss HB, Herrstedt J, Eisenberg PD, Raftopoulos H, Grunberg SM, Gabriel M, Rodgers A, Bohidar N, Klinger G, Hustad CM, Horgan KJ, Skobieranda F (2005) Efficacy and tolerability of aprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients with breast cancer after moderately emetogenic chemotherapy. J Clin Oncol 23:2822–2830CrossRef
26.
go back to reference Rapoport BL, Jordan K, Boice JA, Taylor A, Brown C, Hardwick JS, Carides A, Webb T, Schmoll HJ (2010) Aprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with a broad range of moderately emetogenic chemotherapies and tumor types: a randomized, double-blind study. Support Care Cancer 18:423–431CrossRef Rapoport BL, Jordan K, Boice JA, Taylor A, Brown C, Hardwick JS, Carides A, Webb T, Schmoll HJ (2010) Aprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with a broad range of moderately emetogenic chemotherapies and tumor types: a randomized, double-blind study. Support Care Cancer 18:423–431CrossRef
27.
go back to reference Burmeister H, Aebi S, Studer C, Fey MF, Gautschi O (2012) Adherence to ESMO clinical recommendations for prophylaxis of chemotherapy-induced nausea and vomiting. Support Care Cancer 20:141–147CrossRef Burmeister H, Aebi S, Studer C, Fey MF, Gautschi O (2012) Adherence to ESMO clinical recommendations for prophylaxis of chemotherapy-induced nausea and vomiting. Support Care Cancer 20:141–147CrossRef
28.
go back to reference Ng T, Mazzarello S, Wang Z, Hutton B, Dranitsaris G, Vandermeer L, Smith S, Clemons M (2016) Choice of study endpoint significantly impacts the results of breast cancer trials evaluating chemotherapy-induced nausea and vomiting. Breast Cancer Res Treat 155:337–344CrossRef Ng T, Mazzarello S, Wang Z, Hutton B, Dranitsaris G, Vandermeer L, Smith S, Clemons M (2016) Choice of study endpoint significantly impacts the results of breast cancer trials evaluating chemotherapy-induced nausea and vomiting. Breast Cancer Res Treat 155:337–344CrossRef
Metadata
Title
Incidence of nausea and vomiting in breast cancer patients treated with anthracycline plus cyclophosphamide-based chemotherapy regimens in Italy: NAVY observational study
Authors
Michelino De Laurentiis
Chiara Bonfadini
Vito Lorusso
Giuseppina Cilenti
Francesca Di Rella
Giuseppe Altavilla
Manuela Otero
Antonio Ardizzoia
Paolo Marchetti
Giorgia Peverelli
Domenico Amoroso
Stefania Vecchio
Elena Fiorio
Simona Orecchia
Publication date
01-12-2018
Publisher
Springer Berlin Heidelberg
Published in
Supportive Care in Cancer / Issue 12/2018
Print ISSN: 0941-4355
Electronic ISSN: 1433-7339
DOI
https://doi.org/10.1007/s00520-018-4259-1

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